Deerfield, IL, United States
Deerfield, IL, United States

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Patent
Cytochroma and Proventiv Therapeutics LLC | Date: 2014-08-06

The invention provides 25-hydroxyvitamin D for use in the treatment of hyperparathyroidism by controlled release. The 25-hydroxyvitamin D is administered by intravenous delivery, especially in dosage amounts of from 1 to 100 g per day. The 25-hydroxyvitamin D may be (a) 25-hydroxyvitamin D2 or (b) 25-hydroxyvitamin D3 or (c) a combination of 25-hydroxyvitamin D2 and 25-hydroxyvitamin D3.


Patent
Proventiv Therapeutics Llc and Cytochroma | Date: 2012-11-19

The method of treating elevated blood levels of iPTH by increasing or maintaining blood concentrations of both 25-hydroxyvitamin D and 1,25-dihydroxyvitamin D in a patient by administering, as necessary, both Vitamin D repletion and Vitamin D hormone replacement therapies, is disclosed. The blood concentrations of 25-hydroxyvitamin D are increased to and maintained at or above 30 ng/mL, and blood concentrations of 1,25-dihydroxyvitamin D are increased to or maintained within a patients normal historical physiological range for 1,25-dihydroxyvitamin D without causing substantially increased risk of hypercalcemia, hyperphosphatemia or over suppression of plasma iPTH in the patient. The blood levels of 25-hydroxyvitamin D are maintained at or above 30 ng/mL between doses of Vitamin D repletion therapies, and the blood levels of 1,25-dihydroxyvitamin D are maintained in the patients normal historical physiological range between doses of Vitamin D hormone replacement therapies. In one aspect, the disclosure includes methods wherein the blood concentration of 25-hydroxyvitamin D during treatment comprises predominantly 25-hydroxyvitamin D_(3), and/or wherein the method includes administering predominantly or solely 25-hydroxyvitamin D_(3 )for 25-hydroxyvitamin D repletion and/or maintenance.


Patent
Proventiv Therapeutics Llc and Cytochroma | Date: 2013-01-22

A stable, controlled release formulation for oral dosing of vitamin D compounds is disclosed. The formulation is prepared by incorporating one or more vitamin D compounds into a solid or semi-solid mixture of waxy materials. Oral dosage forms can be prepared by melt-blending the components described herein and filling gelatin capsules with the formulation.


Patent
Proventiv Therapeutics LLC and Cytochroma | Date: 2014-01-01

A method of treating elevated blood levels of iPTH by increasing or maintaining blood concentrations of both 25-hydroxyvitamin D and 1,25-dihydroxyvitamin D in a patient by administering, as necessary, both Vitamin D repletion and Vitamin D hormone replacement therapies, is disclosed. The blood concentrations of 25-hydroxyvitamin D are increased to and maintained at or above 30 ng/mL, and blood concentrations of 1,25-dihydroxyvitamin D are increased to or maintained within a patients normal historical physiological range for 1,25-dihydroxyvitamin D without causing substantially increased risk of hypercalcemia, hyperphosphatemia or over suppression of plasma iPTH in the patient. The blood levels of 25-hydroxyvitamin D are maintained at or above 30 ng/mL between doses of Vitamin D repletion therapies, and the blood levels of 1,25-dihydroxyvitamin D are maintained in the patients normal historical physiological range between doses of Vitamin D hormone replacement therapies. In one aspect, the disclosure includes methods wherein the blood concentration of 25-hydroxyvitamin D during treatment comprises predominantly 25-hydroxyvitamin D_(3), and/or wherein the method includes administering predominantly or solely 25-hydroxyvitamin D_(3) for 25-hydroxyvitamin D repletion and/or maintenance.


Patent
Cytochroma and Proventiv Therapeutics LLC | Date: 2012-08-01

A stable, controlled release formulation for oral dosing of vitamin D compounds is disclosed. The formulation is prepared by incorporating one or more vitamin D compounds into a solid or semi-solid mixture of waxy materials. Oral dosage forms can be prepared by melt-blending the components described herein and filling gelatin capsules with the formulation.


Patent
Johns Hopkins University and Cytochroma | Date: 2011-01-13

This present disclosure is directed to novel prodrugs of activated vitamin D3 compounds. The prodrugs can be designed to have one or more beneficial properties, such as selective inhibition of the enzyme CYP24, low calcemic activity, and anti-proliferative activity. Specifically, these prodrugs are 1-deoxy prohormones of active Vitamin D analogs, e.g. analogs of calcitriol. This disclosure is also directed to pharmaceutical and diagnostic compositions containing the prodrugs of the invention, and to their medical use, particularly as prodrugs in the treatment and/or prevention of diseases.


A stabilized 1,25-dihydroxyvitamin D_(2 )composition which is particularly well suited for pharmaceutical formulations, pharmaceutical formulations of the 1,25-dihydroxyvitamin D_(2 )composition, and a method of making the purified composition by purifying a crude 1,25-dihydroxyvitamin D_(2 )from acetone/water, are disclosed.


Patent
Cytochroma | Date: 2013-10-28

A mixed metal compound for pharmaceutical use is free from aluminium and has a phosphate binding capacity of at least 30%, by weight of the total weight of phosphate present, over a pH range of from 2-8. The compound is especially useful for treatment of hyperphosphataemia. The metals are preferably iron (III) and at least one of calcium, magnesium, lanthanum and cerium. A metal sulphate for pharmaceutical use is selected from at least one of calcium, lanthanum and cerium sulphate compounds and has a phosphate binding capacity of at least 30% by weight of the total phosphate present, over a pH range from 2-8.


Patent
Cytochroma | Date: 2014-03-24

There is provided a method of producing a mixed metal compound comprising at least Mg^(2+) and at least Fe^(3 +) having an aluminium content of less than 10000 ppm, having an average crystal size of less than 20 nm (200 A) comprising the steps of: (a) combining a Mg^(2+) salt and a Fe^(3 +) salt with Na_(2)CO_(3 )and NaOH to produce a slurry, wherein the pH of the slurry is maintained at from 9 5 to 1 1, and wherein the Na_(2)CO_(3 )is provided at an excess of 0 to 4.0 moles than is required to complete the reaction (b) subjecting the slurry to mixing under conditions providing a power per unit volume of 0 03 to 1.6 kW/m^(3 )(c) separating the mixed metal compound from the slurry, to obtain a crude product having a dry solid content of at least 10 wt % (d) drying the crude product either by (i) heating the crude product to a temperature of no greater than 150 C. and sufficient to provide a water evaporation rate of 0.05 to 1 5 kg water per hour per kg of dry product, or (H) exposing the crude product to rapid drying at a water evaporation rate of 500 to 50000 kg water per hour per kg of dry product.


There is provided a granular material comprising (i) at least 50% by weight based on the weight of the granular material of solid water-insoluble mixed metal compound capable of binding phosphate of formula (I): M^(II)_(1-x).M^(III)_(x)(OH)_(2)A^(n)_(y).zH_(2)O (I) where M^(II )is at least one of magnesium, calcium, lanthanum and cerium; M^(II )is at least iron(III); A is at least one n-valent anion; x=ny, 0

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